Trigeminal Neuralgia (TN) is a clinical condition characterized by debilitating pain in regions of the face innervated by one or more divisions of the trigeminal nerve. The pain is typically described as intense, sharp and stabbing, and is often described as one of the most painful conditions known to mankind.
In December 2015, Capnia received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for its nasal, non-inhaled carbon dioxide (nasal CO2) technology for the treatment of TN.
The use of Capnia’s nasal CO2 product for the treatment the pain associated with TN is supported by preclinical and clinical data demonstrating that CO2 may inhibit sensory nerve activation, subsequent release of neuropeptides, and alleviate trigeminally-mediated pain. Collectively, these data suggest that nasal CO2 may provide relief of symptoms associated with TN.
Upon FDA approval of nasal CO2 for the treatment of the pain associated with TN, the orphan drug designation provides Capnia’s nasal CO2 therapeutic technology with certain benefits, including seven years of U.S. market exclusivity in the specific indication.
For more information about the Pilot clinical trial please visit ClinicalTrials.gov (NCT02473016).